NCT00614068

Brief Summary

This study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

February 11, 2008

Last Update Submit

April 3, 2015

Conditions

Post-Traumatic Stress Disorder

Keywords

TreatmentPTSD

Outcome Measures

Primary Outcomes (1)

  • University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index

    Measured at baseline and Month 3

Study Arms (2)

A

EXPERIMENTAL

Participants will receive 12 sessions of trauma-focused cognitive behavioral therapy over 3 months.

Behavioral: Trauma-focused cognitive behavioral therapy (TF-CBT)

B

ACTIVE COMPARATOR

Participants will receive 12 sessions of treatment as usual over 3 months.

Behavioral: Treatment as usual (TAU)

Interventions

Trauma-focused cognitive behavioral therapy (TF-CBT)BEHAVIORAL

TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD.

A
Treatment as usual (TAU)BEHAVIORAL

TAU outpatient sessions will include routine community care and nontrauma-focused therapy.

B

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Seeking services at Jewish Board of Family and Children's Services outpatient clinics
  • Meets DSM-IV criteria for PTSD
  • Stable on medication for 1 month before study entry
  • English-speaking

You may not qualify if:

  • Active suicidality or anyone whose life circumstances might be considered peri-traumatic (e.g., active current abuse)
  • Uncontrolled psychosis
  • Severe mental retardation or severe brain damage
  • Severe language comprehension barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Jewish Board of Family and Children's Services (Yeshiva Chanoch Lenaar)

New York, New York, 10019, United States

Location

Jewish Board of Family and Children's Services (Staten Island)

New York, New York, 10314, United States

Location

Jewish Board of Family and Children's Services (Beatman)

New York, New York, 10463, United States

Location

Jewish Board of Family and Children's Services (Pelham)

New York, New York, 10467, United States

Location

Jewish Board of Family and Children's Services (BoroPark)

New York, New York, 11219, United States

Location

Jewish Board of Family and Children's Services (Break-Free Adolescent Services)

New York, New York, 11223, United States

Location

Jewish Board of Family and Children's Services (South Brooklyn)

New York, New York, 11223, United States

Location

Jewish Board of Family and Children's Services (Pride)

New York, New York, 11362, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Claude M. Chemtob, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Rohini Luthra, PhD

    Icahn School of Medicine at Mount Sinai

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 13, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2008

Study Completion

February 1, 2009

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

US(8)